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NCT01258517 Clinical Trial

The Effect of Surfactant Administration on Cerebral Oxygenation

Respiratory Distress Syndrome Clinical Trial

Official title:
The Effect of the Type and the Method of Surfactant Administration on Oxygenation in Preterm Infants: a Near Infrared Spectroscopy Study

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01258517
Other study ID # NIRS-018
Secondary ID
Status Suspended
Phase N/A
First received December 7, 2010
Last updated September 1, 2016
Start date November 2010
Est. completion date December 2018

Study information
Verified date November 2010
Source Zekai Tahir Burak Women's Health Research and Education Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess changes in cerebral oxygenation during two different types (beractant and poractant) and two different routes (double lumen or single lumen endotracheal tube) of surfactant administration using near infrared spectroscopy (NIRS).

Recruitment information / eligibility
Status Suspended
Enrollment 40
Est. completion date December 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Both
Age group 23 Weeks to 32 Weeks
Eligibility Inclusion Criteria:

Clinical diagnosis of respiratory distress syndrome <32 gestational weeks and/or <1500 g birthweight

Exclusion Criteria:

major congenital anomalies complex congenital heart diseases

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• near infrared spectroscopy (INVOS 5100)
monitorization of cerebral oxygenation by INVOS 5100 during surfactant administration

Locations
Country Name City State
Turkey Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive Care Unit Ankara

Sponsors (1)
Lead Sponsor Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary to determine the optimal and the most safe surfactant administration technique with regard to cerebral oxygenation as measured by near infrared spectroscopy in low birth weigh infants up to 36 weeks Yes
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